FDA Commissioner Scott Gottlieb is off to a running start. Just look what’s happened in four short months:

The first device recall over cybersecurity (a pacemaker)

Final guidance re: device interoperability

New guidance re: use of real-world experience in device approvals

New small-business guidance re: applying for lower user fees

Clarification of early feasibility study program for early-stage devices

And Gottlieb is just getting started.

His big-picture approach to device regulation has yet to emerge, as does

What role patients will play in device development and approval, and

How the FDA will sort out knotty issues surrounding combination products.

FDAnews’s expert panelists are ready with answers.

Mark the calendar for Thursday, Oct. 12 and Part II of the standout FDAnews Expert Insight Series. Attendees will hear from five of the most insightful FDA experts at work today as they track the path of the Gottlieb FDA and medical device regulation:

Wayne Pines, chief FDA spokesman for seven years. Mr. Pines was FDA Alumnus of the Year (2004). He now advises FDA-regulated clients on crisis communications.

Peter Pitts, top policy adviser to FDA Commissioner McClellan among other FDA leadership positions. While at the FDA Mr. Pitts worked directly with Scott Gottlieb. He now heads the Center for Medicine in the Public Interest.

Marc Scheineson Esq., partner, Alston & Bird LLP. As FDA associate commissioner for legislative affairs, Mr. Scheineson was active on Rx user fees, debarment, medical device amendments and nutrition labeling, among other innovative policies. He has also served as a counsel to the House Ways & Means Committee.

Dan Kracov Esq., Partner, Arnold & Porter Kaye Scholer LLP. As one of the nation’s foremost FDA legal practitioners, Mr. Kracov is known for expertise in development, approval and marketing of FDA-regulated products — not only drugs and devices but also foods, dietary supplements and cosmetics.

The topic of the day is devices, but don’t be surprised if panelists range beyond it to matters affecting other FDA-regulated health science firms. Plan to listen in even if devices aren’t a main concern. Devicemakers will be participating Thursday, Nov. 16 for Part III, when drugs and biologics are on the agenda. And everyone is advised to mark their calendars for the final session Thursday, Dec. 14: Global Regulation and a Look Ahead.

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.